FDA.reportPublic FDA data

ANTISEPTIC WIPE

Product NDC
55550-221
11-digit product format
555500221
Labeler code
55550
Product ID
55550-221_b36d050b-cde5-42ec-b26d-9e165c8a0630
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
PATCH
Route
TOPICAL
Labeler
Total Resources International Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-17
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ANTISEPTIC WIPE
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf4a6a97-529e-7f11-e053-2a95a90a75a9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-221-012023-02-01C16284748780-1f386c649-c9fc-0266-e053-dadaa90a7c1aDrug Facts
55550-221-012023-02-01C16284748780-1f386c649-c9fc-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-221-01ANTISEPTIC WIPE011.6 g in 1 PATCHPATCH1.69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-221ANTISEPTIC WIPE 01 (BENZALKONIUM CHLORIDE) PATCH [TOTAL RESOURCES INTERNATIONAL INC.]8Current NDC, Legacy NDC, 1 package rows20250101_cf4a6a97-529e-7f11-e053-2a95a90a75a9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 33 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEValu Merchandisers Company8235b54f-2468-45ca-bff0-9149e582e8862026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
application number: M003
IodineIODINEUnited Natural Foods, Inc. dba UNFI8e840855-d210-4a99-b73f-6c69dcf2b6fb2026-02-16WarningsExact identifier
application number: M003
IODDO IODINEIODINEEVI LABS4af8552c-1f2b-84ad-e063-6394a90abb622026-02-16WarningsExact identifier
application number: M003
SaniiSwabETHYL ALCOHOL 62%PolleyMed LLC3b06f3a4-de7f-0d16-e063-6394a90af0dc2026-02-14WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETopco Associates LLCe258fbd2-f1dd-4ba0-ac9b-64246f2db50b2026-02-13Warnings, Adverse reactionsExact identifier
application number: M003
Iodine TinctureIODINE TINCTURETopco Associates LLCe648f206-cc4f-4f5f-b31c-2fb8bf2708a72026-02-13Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDETopco Associates LLCc3509fd3-e1bc-42bd-881e-7fb520ace9f92026-02-13WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalgreen Co.b1c71ff1-8ffa-46df-9b43-86ed062c3a982026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
IodineIODINEWalgreen Co.d3d44c9f-4eb6-4e5b-9943-c0f80f06952d2026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalgreen Co.eea239fe-554f-4487-9312-3ab0af27d5302026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Consortium, LLCd7154398-4f52-434a-b51b-b7829ccebf3b2026-02-12WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP26e10080-d389-4994-e054-00144ff8d46c2026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LPd980969d-694b-4c9e-a931-73beaceb51da2026-02-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
application number: M003
Hydrogen Peroxide First Aid AntisepticHYDROGEN PEROXIDEMedline Industries, LP4593f51a-9bcb-4149-9ce4-4f62183fd3dd2026-02-11WarningsExact identifier
application number: M003
Hydrogen peroxideHYDROGEN PEROXIDEMedline Industries, LP26a67a91-ee2d-6a6c-e054-00144ff88e882026-02-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNcf4a6a97-529e-7f11-e053-2a95a90a75a99
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDcf4a6a97-529e-7f11-e053-2a95a90a75a99
1038558benzalkonium chloride 0.13 % Topical ClothSYcf4a6a97-529e-7f11-e053-2a95a90a75a99
1038558benzalkonium chloride 0.13 % Topical SwabSYcf4a6a97-529e-7f11-e053-2a95a90a75a99
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYcf4a6a97-529e-7f11-e053-2a95a90a75a99
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYcf4a6a97-529e-7f11-e053-2a95a90a75a99
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYcf4a6a97-529e-7f11-e053-2a95a90a75a99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55550-221-01555500221011.6 g in 1 PATCH (55550-221-01) 1.6 g2021-11-172049-12-31NoNoCurrent